The high cost and risks associated with the research and development of new drugs demand an alert as well as realistic legislative policy at both national and international levels. Registration of a new drug required before a marketing licence is granted, is important for all branches of the pharmaceutical industry but is crucial for success in the innovative biotechnological sector.
Innovation as such is no guarantee to be profitable. Increasing government demands have introduced uncertainty on whether new products will secure registration and have led to a disproportionate increase in the economical risks for innovative industry. Preparation and submission of an application for registration should be undertaken seriously and professionally since it has significantly more consequences than simply obtaining a marketing licence. It will influence marketing strategies and results. It is proposed — since dealing with regulatory affairs can be considered as an essential specialism — to apply a Quality Assurance approach. Activities in this context should comply with the same performance standards as developed for GMP, GLP and GCP leading to Good Regulatory Practice (GRP).
By acknowledging regulatory affairs as a quality assurance means one can define a set of standard procedures within an organization to ensure that decisions are made on current and future regulations. In such a setup regulatory affairs becomes a marketing tool.
This paper illustrates the complex problems found in registration activities. It underlines the necessity of introducing a GRP-approach of performance resulting in substantive evidence of regulatory efficacy.
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References and notes
Rules governing pharmaceuticals in the European Community; Commission of the European Communities, 111/13/6 - Pharmaceuticals, Veterinary Medicines, June 1987; also published as:
Rules governing pharmaceuticals in the European Community; Sauer F, Hankin R, J Clin Pharmacol 1987; 27: 639–46.
The rules governing medicaments for human use in the European Community; Commission of the European Communities, III/182/87 (text completed in July 1987), covering Council directives- 65/65/EEC of 26.1.65 (OJ NO. 22, 9.2.65)- 75/138/EEC of 20.5.75 (OJ L 147, 9.6.75)- 75/319/EEC of 20.5.75 (OJ L 147, 9.6.75)- 78/25/EEC of 12.12.77 (OJ L 11, 14.1.78)- 83/189/EEC of 28.3.83 (OJ L 109, 26.4.83)- 83/570/EEC of 26.10.83 (OJ L 332, 28.11.83)- 87/18/EEC of 18.12.86 (OJ L 15, 17.1.87)- 87/19/EEC of 22.12.86 (OJ L 15, 17.1.87)- 87/21/EEC of 22.12.86 (OJ L 15, 17.1.87)- 87/22/EEC of 22.12.86 (OJ L 15, 17.1.87) Council recommendations- 83/571/EEC of 26.10.83 (OJ L 332, 28.11.83),- 87/176/EEC of 9.2.87 (OJ L 73, 16.3.87).
Commission communications- on parallel imports (OJ C 115, 5.6.82)- on price controls and reimbursement of medicinal products (OJ C 310, 12.4.86)
III/158/85, final of April 1986: Notice to applicants for marketing for proprietary medicinal products in the member states of the European Community on the use of the new multi-state procedure created by council directive 83/570/EEC III/118/87, Rev. 6 of March 1988: Notice to applicants for the marketing for propietary medicinal products in the member states of the European Community
Notes to applicants for marketing authorizations:- On the production and quality control of monoclonal antibodies of murine origin intended for use in man (III/859/86, Re. 7, Final, June 1987).- On the production and quality control of medicinal products derived by recombinant DNA technology (III/860/86, Rev. 8, Final, June 1987).
Draft guidelines/notes to applicants (to be finalized during 1988 or later: not all ref. numbers were known at date of publication):- general rules and scientific principles for the conduct of clinical trials;- trials in children;- trials in the elderly;- anti-arrhytmic drugs;- stability tests on active substances and finished products (III/66/87);- anticancer drugs;- antidepressant drugs;- drugs for cardiac insufficiency;- data required before clinical trials;- toxicity testing of products derived from biotechnology (III/407/87);- local toxicity;- chemistry of the active ingredients (111/478/87);- development pharmaceuticals and process validation (III/847/87);- analytical validation.
Extension of pharmaceutical directives to medicinal products not yet covered (to be enforced not later than 1-1-1991)- Proposal for a council directive amending directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products- Proposal for a council directive amending directives 65/65/EEC, and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products and 1. Immunological medicinal products consisting of vaccines, l. Immunological medicinal products consisting of vaccines, toxins or serums and allergenes (III/... /87) 2. Medicinal products derived from human blood (III/2250/87) 3. Radiopharmaceuticals (III/... /87) 4. Homeopathic medicinal products (111/2175/87)9. Veterinary products: Council directive 81/851/EEC of 28.9.81 on the approximation of the laws of member states relating to veterinary medicinal products (OJ L 317, 11.6.81) Council directive 81/852/EEC of 28.9.81 on the approximation of the laws of member states relating to analytical, pharmacotoxicologic and clinical standards and protocols in respect of the testing of veterinary medicinal products (OJ L 317, 11.6.81) Council directive 87/20/EEC of 22.12.86, amending Directive 81/852/EEC on the approximation of the laws of member states relating to analytical, pharmacotoxicologic and clinical standards and protocols in respect of the testing of veterinary medicinal products (OJ L 15, 1.17.87)
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Tryzelaar, B. Regulatory affairs and biotechnology in Europe. Biotherapy 1, 59–69 (1989). https://doi.org/10.1007/BF02170136
- Quality Assurance
- Performance Standard
- International Level
- Substantive Evidence
- Marketing Strategy